A kind of detection method of impurity content in ambroterol oral solution
A technology of impurity content and detection method, which is applied in the detection field, can solve the problems of inability to effectively monitor the impurity situation of ambroterol oral solution, inability to effectively separate clenbuterol hydrochloride and preservative components, inability to obtain excipients and clenbuterol hydrochloride Effective separation of problems, to achieve the effect of eliminating serious interference, high specificity, and efficient batch detection
Active Publication Date: 2022-07-26
NANJING TECH UNIV
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Problems solved by technology
[0004] The detection methods for related substances in the quality standards of ambroxol hydrochloride recorded in the pharmacopoeias of various countries are only applicable to the single preparation of ambroxol hydrochloride, and cannot effectively separate the components of clenbuterol hydrochloride and preservatives contained in this product
[0005] Chinese patent CN113049687A discloses a detection method for ambroxol hydrochloride raw materials and related substances in injections. The method adopts an isocratic elution method. Since this product is a compound preparation of ambroxol and is an oral solution, it contains various auxiliary materials. The interference it produces is far greater than that of raw materials and injections. This method cannot effectively separate the excipients and clenbuterol hydrochloride contained in this product, and cannot achieve the purpose of rapid detection of trace impurities
[0006] In summary, there is still no detection method for related substances in ambroterol oral solution, and it is impossible to effectively monitor the impurities in ambroterol oral solution and ensure the quality of ambroterol oral solution. An effective method for impurity detection
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[0038] The present invention can be better understood from the following examples.
[0039] The reagents used in the examples of the present invention are all chromatographically pure, unless otherwise specified.
[0040] 1. Reagents and materials
[0041] Diamine hydrogen phosphate, ammonia water, phosphoric acid, acetonitrile, tetrahydrofuran.
[0042] Ambroxol hydrochloride reference substance (source: China National Institute for Food and Drug Control, batch number: 100599-202106, content: 100%);
[0043] Clenbuterol hydrochloride reference substance (source: China National Institute for Food and Drug Control, batch number: 100072-201503, content: 90.5%);
[0044] Impurity A reference substance (source: China National Institute for Food and Drug Control, batch number: 510025-201702, content: 100%);
[0045] Impurity B reference substance (source: China National Institute for Food and Drug Control, batch number: 510026-202003, content: 100%);
[0046] Impurity C referen...
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Abstract
The invention discloses a method for detecting the content of impurities in ambroterol oral solution. The method adopts high performance liquid chromatography to detect, uses octadecylsilane bonded silica gel as a filler, and uses 9 mol / L to 11 mol / L hydrogen phosphate. The aqueous solution of diammonium is the mobile phase A; the acetonitrile solution containing 0.1 vt.% tetrahydrofuran is used as the mobile phase B, and gradient elution is carried out, the column temperature is 35-45 °C, and the flow rate is 0.8-1.2 ml per minute. The method for detecting the content of impurities in the ambroterol oral solution effectively monitors the quality of the ambroterol oral solution, and the method has high specificity, and neither the blank auxiliary material nor the solvent interferes with the detection of known impurities.
Description
technical field [0001] The invention belongs to the field of detection methods and relates to a method for detecting related substances in ambroterol oral solution, in particular to the detection of organic impurities such as degradation products of ambroterol oral solution. Background technique [0002] Ambroxol oral solution is a compound preparation composed of ambroxol hydrochloride and clenbuterol hydrochloride, in which ambroxol hydrochloride is a mucolytic agent, which has the properties of promoting mucus removal and dissolving secretions, and can promote the viscosity of the respiratory tract. Exclusion of secretions and reduction of mucus retention; Clenbuterol hydrochloride is a β2-receptor agonist and belongs to adrenomimetic drugs, which can relax bronchial smooth muscle and have anti-asthmatic effects. [0003] At present, with regard to the related substance detection method of ambroterol oral solution, there is no related substance detection method for this v...
Claims
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IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N30/86
Inventor 李向玲吴宇王子恒谢婧婧
Owner NANJING TECH UNIV